Evaluation of Microbiota Transplant Therapy in Patients With Alopecia Areata

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Minnesota

About this trial

Alopecia Areata (AA) is among the most highly prevalent human autoimmune diseases, leading to disfiguring hair loss due to the collapse of immune privilege of the hair follicle and subsequent autoimmune attack. AA affects about 5.3 million people in the United States alone, including males and females across all ethnic groups, with a lifetime risk of 2.1%. Autoimmunity develops against the hair follicle, resulting in non-scarring hair loss that may begin as patches that can coalesce and progress to cover the entire scalp (alopecia totalis) or eventually the entire body (alopecia universalis). In AA, there is no permanent destruction of the hair follicle, and regrowth remains possible. Treatment options for AA include intralesional steroids, topical anthralin, allergic contact dermatitis with diphencyprone (DPCP), dinitrochlorobenzene (DNCB), or squaric acid dibutyl ester (SADBE), and recently janus kinase ( JAK) inhibitors. Despite the recent approval of JAKs for the treatment of extensive alopecia areata, some patients are treatment resistant, suffer relapses, or cannot take an oral immunosuppressive medication.

This study will attempt to elucidate the pre-treatment and post treatment skin and gut microbiome composition to determine whether specific bacterial species may correlate with disease or treatment response. To determine the effects of MTT on immune cell composition and activation systemically and locally in the skin, we will analyze major immune cell populations in peripheral blood samples and collect skin biopsies for histopathology and next generation sequencing analyses. Further, to determine if changes in immune cell populations affect the inflammatory response, we will profile inflammatory cytokines. To identify if changes in the gut microbiota influence the metabolic signature in AA, we will also perform untargeted metabolomics in stool gut microbiome samples and in plasma. Altogether, this comprehensive approach aims to identify the pathogenic immunological mechanisms associated with microbiome composition correlated to pre-treatment disease, post-treatment response, and any non-responders to treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 18 to 75 years of age with moderate to severe alopecia areata (SALT score >30%).

Patients with a diagnosis of patch type alopecia areata, totalis, or universalis..

Duration of hair loss >=3 months..

No evidence of active, ongoing regrowth present at baseline.

Disqualifiers

Active gastrointestinal infection at time of enrollment.

Having been administered antibiotics in the last 48 hours.

Patients will be eligible to enroll if antibiotic therapy is discontinued for at minimum 48 hours prior to treatment..

Requires continued antibiotic use

Trial design

Design model

Crossover

Treatments tested in this trial

  • Vancomycin, Neomycin and MTT capsules

    Drug

    patients will take 2 capsules per day for 14 days. These patients will then be clinically followed for a period of 24 weeks.

  • Placebo capsules

    Drug

    patients will take 2 capsules per day for 14 days. These patients will then be clinically followed for a period of 24 weeks.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Alopecia Areata study groupExperimental treatment 1 intervention
Group B: Alopecia Areata control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Engraftment

Proportion of patients achieving donor microbiota engraftment measured at 8 weeks post treatment.

Time frame
Week 8

Secondary outcomes

1

Hair regrowth

Percent hair regrowth from baseline determined by SALT measurements following 8, 16, 24, 26, 34, 42, 50 and 54 weeks post treatment.

Time frame
8, 16, 24, 26, 34, 42, 50 and 54 weeks post treatment
2

efficacy measure 2

Timing of relapse in responders followed for 6 months post therapy.

Time frame
6 months post therapy
3

SALT Score

Proportion of patients in the treatment versus placebo group achieving SALT score of \<50% at week 24

Time frame
Week 24
4

safety outcome 2

Proportion of participants with a SAE through day 30 (±3 days) after MTT.

Time frame
day 30

Other outcomes

Sponsors and contacts

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University of Minnesota

Lead sponsor

Columbia University

Collaborator